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Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies


Phase 2
N/A
70 Years
Not Enrolling
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies


OBJECTIVES:

Overall survival-12 months

Overall survival-24 months

Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant

Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months
post transplant

Chronic Graft-versus-Host Disease Matched Related patients- up to 2 years post transplant

Chronic Graft-versus-host disease Unrelated and Mismatched related patients- up to 2 years
post transplant

- OUTLINE: Patients are stratified according to donor type (HLA-matched related vs
HLA-matched unrelated, single HLA-allele disparate related, or unmatched)
(HLA-mismatched related or matched unrelated donor stratum closed to accrual as of
1/11/06).

Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days
-8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes
on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day
0.

Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12
hours beginning on day -1 and continuing orally as tolerated until day 100.

Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6
months for 1 year, and then annually thereafter or as clinically indicated.

PROJECTED ACCRUAL: A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched
related or matched unrelated) will be accrued for this study within 2 years (HLA-mismatched
related or matched unrelated donor stratum closed to accrual as of 1/11/06).

Inclusion Criteria


INCLUSION CRITERIA:

- Disease criteria: This trial is primarily designed for: 1) patients with relapsed or
primary refractory non-Hodgkin's lymphoma, 2) chemosensitive relapsed or refractory
acute and chronic lymphocytic leukemias, 3) relapsed or primary refractory Hodgkin's
Disease, or advanced (Durie-Salmon stage II or III) multiple myeloma, advanced
Waldenstrom macroglobulinemia, who, by virtue of advanced age, intensity of prior
radiation and/or chemotherapy, history of prior toxicity associated with
chemo/radiotherapy or existing organ dysfunction, would be at undue risk of regimen
associated mortality if transplanted according to protocols involving myeloablative
conditioning regimens.

- Patients with aggressive NHL histologies must have chemo/radiosensitive disease, or
have non-progressive disease, or have stable disease on therapy, and be ineligible
for an autologous HSC transplant because of disease in the marrow.

- Patients with chronic myeloid leukemia and high risk forms of acute myelogenous
leukemia or myelodysplastic syndromes are also eligible in the absence of an
alternative active higher priority allogeneic transplant protocol for which they are
eligible.

- Age criteria: Patients may be up to 70 years of age. There is no lower age threshold.
Patients above the age of 70 may also participate, after evaluation and approval by
the BMT Service attendings.

- Absence of active or uncontrolled bacterial, viral, or fungal infection that would
contraindicate the use of myelosuppressive chemotherapy.

- Patients must have a healthy HLA-compatible donor, either a matched or single HLA
allele disparate related donor or a similarly compatible unrelated donor recruited
through the National Marrow Donor Program. Related donors must be willing to
participate as research subjects and be willing to receive G-CSF to mobilize PBPC and
undergo leukapheresis to donate PBSC. Unrelated donors identified by the NMDP may
elect to donate either PBSC after treatment with G-CSF, or bone marrow. These
unrelated donors will provide informed consent and their PBSC or bone marrow
donations will be obtained at a qualified donor center participating in the NMDP.

- Each patient must be willing to participate as a research subject and must sign an
informed consent form after discussion of the nature and risks of the study prior to
entering the protocol. Parents or legal guardians of patients who are minors will
sign the consent form for these patients after discussion of the nature and risks of
the study.

EXCLUSION CRITERIA:

- Female patients who are pregnant or lactating.

- Active or uncontrolled viral (including HIV-1), bacterial or fungal infection.

- Severe renal insufficiency (creatinine >2.0 or creatinine clearance < 30mL/minute)

- Severe hepatic dysfunction, as defined by: total bilirubin greater than 2.5 mg/dL and
AST and ALT >3xnl, unless the liver is involved with disease.

- Severe cardiac insufficiency, defined as a resting left ventricular ejection of less
than 30% as measured by echocardiography or radionuclide cardiac angiography.
Patients on cardiac medications for congestive heart failure are eligible, as long as
their LVEF is greater than 30% on medication.

- Severe pulmonary insufficiency, as defined by an adjusted diffusing capacity of less
than 40% of predicted value.

- Karnofsky or Lansky score <40%

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

12 months post transplant

Safety Issue:

No

Principal Investigator

Hugo R. Castro-Malaspina, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

01-092

NCT ID:

NCT00027560

Start Date:

July 2001

Completion Date:

April 2009

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • refractory multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • previously treated myelodysplastic syndromes
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent mantle cell lymphoma
  • Waldenström macroglobulinemia
  • childhood chronic myelogenous leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021